The nurse is teaching a client the importance that a placebo plays in drug research. Which items are appropriate for the nurse to include in the teaching session?
1. The research drug must be compared to an inert substance to determine effectiveness.
2. The placebo will be given to a control group, and those results will be compared to the group taking the research drug.
3. During the trials, neither group will know if they have the placebo drug or the research drug.
4. The research drug will be considered for a New Drug Application (NDA) if it is found to be effective and safe when compared to the placebo drug.
5. Before the clinical trials, the research drug will be tested on select clients against another standard drug used for the same condition.
Correct Answer: 1,2,3,4
Rationale 1: The primary focus of a clinical trial is to provide information regarding the effectiveness of the research drug. The effectiveness of the research drug will be compared to an inert substance taken by a nontreatment group, called the control group.
Rationale 2: The primary focus of a clinical trial is to provide information regarding the effectiveness of the research drug. The effectiveness of the research drug will be compared to an inert substance taken by a nontreatment group, called the control group.
Rationale 3: Clients may have a perceived or actual improvement in a medical condition if they know they are taking the research drug. Clients may also feel there is no improvement if they know they are taking a drug that has inert properties.
Rationale 4: If the research drug continues to show that it is effective and safe, an NDA will be submitted to the Federal Drug Administration (FDA).
Rationale 5: In some cases, the research drug may be compared to a standard drug used for the same condition, but only during clinical trials. Preclinical research does not include testing on humans.
Global Rationale: The primary focus of a clinical trial is to provide information regarding the effectiveness of the research drug. The effectiveness of the research drug will be compared to an inert substance taken by a nontreatment group, called the control group. If the research drug continues to show that it is effective and safe, an NDA will be submitted to the Federal Drug Administration (FDA). In some cases, the research drug may be compared to a standard drug used for the same condition, but only during clinical trials. Preclinical research does not include testing on humans.
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